Matthew Perrone stories from The Center for Public Integrity2018-03-19T10:40:15-04:00https://www.publicintegrity.org/node/20196/rssOpioid makers paid millions to advocacy groups that promoted their painkillers amid addiction epidemic http://www.publicintegrity.org/node/21567A report by U.S. Sen. Claire McCaskill finds opioid drugmakers gave $10 million to advocacy groups that could help spread their message.RTT;Health;Medicine;Drug culture;Oxycodone;Morphinans;Morphine;Euphoriants;Opioid;Opioid epidemic;Fentanyl;Purdue Pharma2018-02-13T09:49:29-05:002018-02-12T19:30:00-05:00<p>Companies selling some of the most lucrative prescription painkillers funneled millions of dollars to <a href="https://www.publicintegrity.org/2016/09/18/20200/politics-pain-drugmakers-fought-state-opioid-limits-amid-crisis">advocacy groups that in turn promoted the medications’ use</a>, according to a report released Monday by a U.S. senator.</p>
<p>The investigation by Missouri’s Sen. Claire McCaskill sheds light on the opioid industry’s ability to shape public opinion and raises questions about its role in an overdose epidemic that has claimed hundreds of thousands of American lives. Representatives of some of the drugmakers named in the report said they did not set conditions on how the money was to be spent or force the groups to advocate for their painkillers.</p>
<p>The report from McCaskill, ranking Democrat on the Senate’s homeland security committee, examines advocacy funding by the makers of the top five opioid painkillers by worldwide sales in 2015. Financial information the companies provided to Senate staff shows they spent more than $10 million between 2012 and 2017 to support 14 advocacy groups and affiliated doctors.</p>
<p>The report did not include some of the largest and most politically active manufacturers of the drugs.</p>
<p>The findings follow a similar investigation launched in 2012 by a bipartisan pair of senators. That effort eventually was shelved and no findings were ever released.</p>
<p>While the new report provides only a snapshot of company activities, experts said it gives insight into how industry-funded groups fueled demand for drugs such as OxyContin and Vicodin, addictive medications that generated billions in sales despite research showing they are largely ineffective for chronic pain.</p>
<p>“It looks pretty damning when these groups were pushing the message about how wonderful opioids are and they were being heavily funded, in the millions of dollars, by the manufacturers of those drugs,” said Lewis Nelson, a Rutgers University doctor and opioid expert.</p>
<p>The findings could bolster hundreds of lawsuits that are aimed at holding opioid drugmakers responsible for helping fuel an epidemic blamed for the deaths of more than 340,000 Americans since 2000.</p>
<p>McCaskill’s staff <a href="https://www.publicintegrity.org/2017/03/28/20785/democratic-senator-investigates-drugmakers-role-opioid-epidemic">asked drugmakers to turn over records</a> of payments they made to groups and affiliated physicians, part of a broader investigation by the senator into the opioid crisis. The request was sent last year to five companies: Purdue Pharma; Insys Therapeutics; Janssen Pharmaceuticals, owned by Johnson &amp; Johnson; Mylan; and Depomed.</p>
<p>Fourteen nonprofit groups, mostly representing pain patients and specialists, received nearly $9 million from the drugmakers, according to investigators. Doctors affiliated with those groups received another $1.6 million.</p>
<p>Most of the groups included in the probe took industry-friendly positions. That included issuing medical guidelines promoting opioids for chronic pain, lobbying to defeat or include exceptions to state limits on opioid prescribing, and criticizing landmark prescribing guidelines from the U.S. Centers for Disease Control and Prevention.</p>
<p>“Doctors and the public have no way of knowing the true source of this information and that’s why we have to take steps to provide transparency,” said McCaskill in an interview with The Associated Press. The senator plans to introduce legislation requiring increased disclosure about the financial relationships between drugmakers and certain advocacy groups.</p>
<p>A <a href="https://www.publicintegrity.org/2016/09/18/20200/politics-pain-drugmakers-fought-state-opioid-limits-amid-crisis">2016 investigation by the AP and the Center for Public Integrity</a> revealed how painkiller manufacturers used hundreds of lobbyists and millions in campaign contributions to fight state and federal measures aimed at stemming the tide of prescription opioids, often enlisting help from advocacy organizations.</p>
<p>Bob Twillman, executive director of the <a href="http://www.integrativepainmanagement.org/">Academy of Integrative Pain Management</a>, said most of the $1.3 million his group received from the five companies went to a state policy advocacy operation. But Twillman said the organization has called for non-opioid pain treatments while also <a href="https://www.publicintegrity.org/2016/09/18/20200/politics-pain-drugmakers-fought-state-opioid-limits-amid-crisis">asking state lawmakers for exceptions to restrictions</a> on the length of opioid prescriptions for certain patients.</p>
<p>“We really don’t take direction from them about what we advocate for,” Twillman said of the industry.</p>
<p>The tactics highlighted in Monday’s report are at the heart of lawsuits filed by hundreds of state and local governments against the opioid industry.</p>
<p>The suits allege that drugmakers misled doctors and patients about the risks of opioids by enlisting “front groups” and “key opinion leaders” who oversold the drugs’ benefits and encouraged overprescribing. In the legal claims, the governments seek money and changes to how the industry operates, including an end to the use of outside groups to push their drugs.</p>
<p>U.S. deaths linked to opioids have quadrupled since 2000 to roughly 42,000 in 2016. Although initially driven by prescription drugs, most opioid deaths now involve illicit drugs, including heroin and fentanyl.</p>
<p><a href="http://www.purduepharma.com/">Purdue Pharma</a>, the maker of OxyContin, contributed the most to the groups, funneling $4.7 million to organizations and physicians from 2012 through last year.</p>
<p>In a statement, the company did not address whether it was trying to influence the positions of the groups it supported, but said it does help organizations “that are interested in helping patients receive appropriate care.” On Friday, Purdue announced it would no longer market OxyContin to doctors.</p>
<p><a href="https://www.insysrx.com/">Insys Therapeutics</a>, a company recently targeted by federal prosecutors, provided more than $3.5 million to interest groups and physicians, according to McCaskill’s report. Last year, the company’s founder was indicted for allegedly offering bribes to doctors to write prescriptions for the company’s spray-based fentanyl medication.</p>
<p>A company spokesman declined to comment.</p>
<p>Insys contributed $2.5 million last year to a <a href="https://uspainfoundation.org/">U.S. Pain Foundation</a> program to pay for pain drugs for cancer patients.</p>
<p>“The question was: Do we make these people suffer, or do we work with this company that has a terrible name?” said U.S. Pain founder Paul Gileno, explaining why his organization sought the money.</p>
<p>Depomed, Janssen and Mylan contributed $1.4 million, $650,000 and $26,000 in payments, respectively. <a href="http://www.janssen.com/">Janssen</a> and <a href="http://www.mylan.com/">Mylan</a> told the AP they acted responsibly, while calls and emails to <a href="http://www.depomed.com/">Depomed</a> were not returned.</p>
<p><em>Perrone and Mulvihill report for <a href="https://apnews.com/2d6203cfb7d34ca68f2bb579c8e80862?utm_campaign=SocialFlow&amp;utm_source=Twitter&amp;utm_medium=AP">The Associated Press</a>.</em></p>
<p><strong>READ MORE:</strong></p>
<p><strong><a href="https://www.publicintegrity.org/2016/09/18//politics-pain-drugmakers-fought-state-opioid-limits-amid-crisis">Politics of pain: Drugmakers fought state opioid limits amid crisis</a></strong></p>
<p><strong><a href="https://www.publicintegrity.org/2016/09/19/20201/pro-painkiller-echo-chamber-shaped-policy-amid-drug-epidemic">Pro-painkiller echo chamber shaped policy amid drug epidemic</a></strong></p>
<p><strong><a href="https://www.publicintegrity.org/2016/12/15/20544/drugmakers-push-profitable-unproven-opioid-solution">Drugmakers push profitable, but unproven, opioid solution</a></strong></p>
Purdue Pharma, the maker of OxyContin pills, gave $4.7 million to advocacy groups that have promoted the medications’ use, according to a new report from U.S.&nbsp;Sen. Claire McCaskill.
Matthew Perronehttps://www.publicintegrity.org/authors/matthew-perroneGeoff Mulvihillhttps://www.publicintegrity.org/authors/geoff-mulvihillDrugmakers push profitable, but unproven, opioid solutionhttp://www.publicintegrity.org/node/20544Drugmakers push policies boosting unproven new opioid formulations as a solution to the addiction epidemic.Ethers;Morphinans;Morphine;Euphoriants;Phenols;Neurochemistry;Opioid;Neuropsychology;Nervous system2016-12-15T10:53:35-05:002016-12-15T05:00:06-05:00<p><em><strong>Editor's note:</strong>&nbsp;This is the latest installment of an ongoing&nbsp;series. The first parts&nbsp;explored&nbsp;the&nbsp;<a href="https://www.publicintegrity.org/2016/09/18/20200/politics-pain-drugmakers-fought-state-opioid-limits-amid-crisis">state political efforts surrounding&nbsp;opioids</a>&nbsp;and how a loose&nbsp;coalition of drugmakers and&nbsp;industry-backed nonprofits shaped the&nbsp;<a href="https://www.publicintegrity.org/2016/09/19/20201/pro-painkiller-echo-chamber-shaped-policy-amid-drug-epidemic">federal response to the opioid crisis</a>.&nbsp;</em></p>
<p>Pilloried for their role in the epidemic of prescription painkiller abuse, drugmakers are aggressively pushing their remedy to the problem: a new generation of harder-to-manipulate opioids that have racked up billions in sales, even though there’s little proof they reduce rates of overdoses or deaths.</p>
<p>More than prescriptions are at stake. Critics worry the drugmakers’ <a href="https://www.publicintegrity.org/2016/09/18/20200/politics-pain-drugmakers-fought-state-opioid-limits-amid-crisis">nationwide lobbying campaign</a> is distracting from more productive solutions and delaying crucial efforts to steer physicians away from prescription opioids — addictive pain medications involved in the deaths of more than 165,000 Americans since 2000.</p>
<p>“If we’ve learned one lesson from the last 20 years on opioids it’s that these products have very, very high inherent risks,” said <a href="https://www.jhsph.edu/faculty/directory/profile/2761/caleb-alexander">Dr. Caleb Alexander</a>, co-director of Johns Hopkins University’s Center for Drug Safety and Effectiveness. “My concern is that they’ll contribute to a perception that there is a safe opioid, and there’s no such thing as a fully safe opioid.”</p>
<p>The latest drugs — known as abuse-deterrent formulations, or ADFs — are generally harder to crush or dissolve, which the drugmakers tout as making them difficult to snort or inject. But they still are vulnerable to manipulation and potentially addictive when simply swallowed. National data from an industry-sponsored tracking system also show drug abusers quickly drop the reformulated drugs in favor of older painkillers or heroin.</p>
<p>In the last two years, pharmaceutical companies have made a <a href="https://www.publicintegrity.org/2016/09/19/20201/pro-painkiller-echo-chamber-shaped-policy-amid-drug-epidemic">concerted under-the-radar push</a> for bills benefiting the anti-abuse opioids in statehouses and in Congress, where proposed legislation would require the <a href="http://www.fda.gov/">Food and Drug Administration</a> to replace older opioids with the new drugs.</p>
<p>The lobbying push features industry-funded advocacy groups and physicians, along with grieving family members, who rarely disclosed the drugmakers' ties during their testimony in support of the drugs.</p>
<p>Besides the tamper-resistant pills, ADF opioids are being rolled out in other forms, including injectable drugs and pills that irritate users when they’re snorted or contain substances that counteract highs.</p>
<p>Making painkillers harder to abuse is a common-sense step. But it’s also a multibillion-dollar sales opportunity, offering drugmakers the potential to wipe out lower-cost generic competitors and lock in sales of their higher-priced versions, which cost many times more than conventional pills. The big companies hold multiple patents on the reformulated drugs, shielding them from competition for years — in some cases decades.</p>
<p>Though abuse-deterrent painkillers represented less than 5 percent of all opioids prescribed last year, they generated more than $2.4 billion in sales, or roughly a quarter of the nearly $10 billion U.S. market for the drugs, according to <a href="http://www.imshealth.com/">QuintilesIMS</a>. The field is dominated by Purdue Pharma’s OxyContin, patent-protected until 2030.</p>
<p>“We at Purdue make certain that prescribers and other stakeholders understand that opioids with abuse-deterrent properties won’t stop all prescription drug abuse, but they are an important part of the comprehensive approach needed to address this public health issue,” <a href="http://www.purduepharma.com/">Purdue</a> spokesman Robert Josephson said in a statement.</p>
<p>Like a spokeswoman for <a href="http://www.pfizer.com/">Pfizer Inc.</a>, Josephson also noted that some public health officials, including the Food and Drug Administration, have endorsed using ADFs.</p>
<p>“We need every tool that we can have in our toolbox,” said Kentucky state <a href="http://www.lrc.ky.gov/Legislator/H066.htm">Rep. Addia Wuchner</a>, a Republican who has worked on several bills to benefit reformulated opioids. “The extra steps are worth the effort in order to prevent this escalation of more addiction.”</p>
<p>The current industry campaign draws on the same 50-state strategy that painkiller manufacturers successfully deployed to help kill or weaken measures aimed at stemming the tide of prescription opioids, a playbook <a href="http://bigstory.ap.org/article/3d257452c24a410f98e8e5a4d9d448a7/pro-painkiller-echo-chamber-shaped-policy-amid-drug">The Associated Press</a> and <a href="https://www.publicintegrity.org/2016/09/18/20200/politics-pain-drugmakers-fought-state-opioid-limits-amid-crisis">Center for Public Integrity</a> exposed in September.</p>
<p>The reporting detailed how opioid drugmakers and the nonprofits they help fund spent more than<a href="https://www.publicintegrity.org/2016/09/18/20200/politics-pain-drugmakers-fought-state-opioid-limits-amid-crisis"> $880 million on lobbying and political contributions</a> at the state and federal level over the past decade, eight times what the gun lobby reported for the same period. The money represents the drugmakers’ spending on all their legislative interests, including opioids.</p>
<p>The FDA has approved a handful of the reformulated drugs but has not yet concluded that any reduce rates of addiction, abuse or death, and the evidence gap has led to diverging views among health authorities.</p>
<p>Whereas FDA regulators emphasize the potential promise of reformulated painkillers, other government officials stress that they contain the same heroin-like ingredients as traditional opioids. An estimated 78 Americans die from heroin and prescription opioid overdoses every day.</p>
<p>“‘Abuse-deterrent’ sounds to people sometimes like ‘Oh, maybe it’s not addictive.’ But it’s no less addictive,” said <a href="https://www.cdc.gov/about/cdcdirector/">Dr. Tom Frieden</a>, head of the Centers for Disease Control and Prevention.</p>
<p>Survey results <a href="http://journals.lww.com/clinicalpain/Citation/2016/04000/Primary_Care_Physicians__Knowledge_And_Attitudes.1.aspx">published</a> this year in the Clinical Journal of Pain showed nearly half of U.S. physicians incorrectly believed that reformulated opioids are less addictive than their predecessors.</p>
<p>Many experts see a key role for ADFs in reducing the number of people who first begin abusing opioids, and some say the abuse-deterrent formulations should be the default painkiller for patients with histories of drug use, anxiety or depression. But even they worry that some drugmakers are overselling the technology. They stress that separate measures are needed for the majority of opioid abusers who ingest the pills orally.</p>
<p>“The way they’re handling the ADF is that this is the answer. And it’s not the answer — it’s part of the bigger puzzle,” said <a href="http://www.psychiatry.wustl.edu/Faculty/FacultyDetails?ID=579">Theodore Cicero</a>, a psychiatry professor at Washington University in St. Louis, who has authored several studies on the drugs.</p>
<p><strong>‘You can’t put a price tag on anybody’s life’</strong></p>
<p>Two years after the overdose that killed her 21-year-old son, Terri Bartlett traveled to Illinois’ state capital to champion an unlikely cause: revamped painkillers.</p>
<p>Bartlett’s son Michael became hooked on Vicodin and later graduated to heroin. In emotional testimony last year, she urged lawmakers to support a bill that would prioritize the new harder-to-crush pills, saying she believed her son would still be alive if abuse-deterrent formulations had been on the market then.</p>
<p>“You can’t put a price tag on anybody’s life,” she said.</p>
<p>Bartlett didn’t know then that she had been recruited into a wide-ranging lobbying campaign.&nbsp;A public relations firm hired by OxyContin-maker Purdue had helped recruit her to support the bill, along with local sheriffs and fire chiefs.</p>
<p>Her words, and similar testimony from parents of drug abusers elsewhere, reflect a tactic used by the drugmakers across the country. For instance, Purdue paid nearly $95,000 for similar lobbying efforts in New York, state records show.</p>
<p>And the industry’s fingerprints are easy to spot in other areas. Of more than 100 bills dealing with the drugs introduced in 35 states in 2015 and 2016, at least 49 featured nearly identical language requiring insurers to cover abuse-deterrent drugs, according to an analysis of data from <a href="https://www.quorum.us/">Quorum</a>, a legislative tracking service. Several of the bill sponsors said they received the wording from pharmaceutical lobbyists.</p>
<p>Since 2012, at least 21 bills related to the drugs have become law, including five that require insurers to pay for the more expensive drugs in Maine, Maryland, Massachusetts, Florida and West Virginia.</p>
<p>Wins in such states will give drugmakers momentum to successfully push for copycat laws elsewhere, noted Paul Kelly, a federal lobbyist who has worked on multistate lobbying campaigns for drugstores and major retailers.</p>
<p>“It’s like a foot in the door,” he said.</p>
<p>Drugmakers have found fierce opposition to their ADF legislation from insurers and employers who would be on the hook for the far pricier opioid variations.</p>
<p>The Illinois bill — and the 48 strikingly similar measures in other states — would require insurers to cover the drugs in the same way as other opioids, which the insurance companies argue would allow drugmakers to charge whatever they want for them.</p>
<p>“That is not the best use of our medical care resources,” Vernon Rowen, vice president of state government affairs for the insurance company <a href="https://www.aetna.com/">Aetna</a>, told Illinois lawmakers after Bartlett testified. “It totally eliminates our ability to negotiate discounts with manufacturers.”</p>
<p>New York Gov. Andrew Cuomo and New Jersey Gov. Chris Christie both vetoed such insurance mandates in the past year, citing the <a href="http://www.njleg.state.nj.us/2014/Bills/A4500/4271_V1.PDF">high costs</a> and <a href="http://static.votesmart.org/static/vetotext/54938.pdf">lack of evidence</a> that the drugs help.</p>
<p>Federal health officials also have pushed back against requirements to cover the drugs, citing the “staggering” costs. For example, a 30-day supply of Pfizer’s abuse-deterrent Embeda, a combination drug containing morphine, costs $268, while a 30-day supply of a generic morphine costs roughly $38, according to data compiled by <a href="http://truvenhealth.com/">Truven Health Analytics</a>, a company that tracks drug prices set by manufacturers.</p>
<p>The <a href="https://www.va.gov/">Department of Veterans Affairs</a>’ Dr. Bernie Good estimated that converting the 8.8 million patient system exclusively to the new reformulations would increase opioid spending more than tenfold, to over $1.6 billion annually. Good, who co-directs the VA’s program for medication safety, said the vast majority of veterans are not at risk for snorting or injecting their medications.</p>
<p>“Would the excess money to pay for abuse-deterrent products — mostly to pay for it in cases where it wouldn’t be necessary — be better spent for drug treatment centers?” he asked at a recent federal meeting on the drugs.</p>
<p>Federal estimates say at least 2.2 million Americans are addicted to prescription opioids or heroin, yet only one in five actually receives treatment, according to a Surgeon General’s <a href="https://www.surgeongeneral.gov/library/2016alcoholdrugshealth/index.html">report</a> published last month. That’s despite some $35 billion already spent annually on substance abuse programs by private and public health providers.</p>
<p>State lawmakers who support the abuse-deterrent bills often defend them as an important piece of solving the opioid puzzle, preventing more costly overdoses and hospitalizations.</p>
<p>And Fred Brason, executive director of <a href="http://projectlazarus.org/">Project Lazarus</a>, a North Carolina-based group that promotes anti-addiction policies in several states, called the focus on the drugs’ cost too narrow.</p>
<p>“You’re already spending that money at the back end,” he said. “You’re spending it at the emergency department.” He also noted the costs of addiction treatment.</p>
<p>When critics raise alarms about higher costs and limited evidence, drugmakers can rely on groups they support financially to argue their side, including the National Association of Drug Diversion Investigators, the Academy of Integrative Pain Management and the Partnership for Drug-Free Kids. Representatives from those groups have testified in favor of abuse-deterrent legislation in at least seven states.</p>
<p>NADDI president <a href="http://naddi.associationdatabase.com/aws/NADDI/asset_manager/get_file/32039/cichon-bio.pdf?ver=17787">Charlie Cichon</a> acknowledged his group receives funds from several ADF-makers, but said it views the drugs as a proven part of the solution to the opioid crisis. “We’re not testifying for Purdue Pharma’s product or Endo’s product,” he said.</p>
<p>And <a href="http://www.aapainmanage.org/profile/bob-twillman/">Bob Twillman</a>, executive director of the Academy, said, “Increased use of abuse-deterrent opioids makes it more likely that those patients who need opiates to treat their pain will be able to get them.”</p>
<p>The <a href="http://www.drugfree.org/">Partnership for Drug-Free Kids</a> did not respond to multiple requests for comment.</p>
<p>Physicians with financial ties to drugmakers play similar roles. Dr. Gareth Shemesh, a pain specialist, testified in support of a Colorado bill last year brought to the sponsoring legislator by Pfizer. Shemesh had received more than $13,500 from Pfizer that year in speaking fees, travel and meals, and more than $5,000 from Purdue the year before. He did not respond to calls for comment, but Pfizer said he was not paid to testify and did not speak on behalf of any specific product.</p>
<p>Purdue and Pfizer also have ramped up contributions to the <a href="http://www.republicanags.com/">Republican</a> and <a href="http://democraticags.org/">Democratic</a> attorneys general associations, which raise unlimited funds to help elect AGs across the country. In 2015 and 2016, they gave a total of $950,000 — more than in the previous four years combined.</p>
<p>To date, 51 attorneys general from U.S. states and territories have signed at least <a href="http://www.naag.org/assets/files/pdf/signons/20130311.Final%20FDA%20Letter.pdf">one</a> of <a href="http://www.naag.org/assets/files/pdf/signons/Final%20FDA%20Abuse%20Deterrent%20Letter.pdf">two</a> National Association of Attorneys General letters to the FDA, urging the agency to favor abuse-deterrent drugs.</p>
<p>The pro-ADF playbook even includes a bit of political theater. In at least seven states, lawmakers or advocates have pounded the reformulated pills with hammers to demonstrate how difficult they are to smash.</p>
<p>In Illinois, it was Democratic <a href="http://www.housedem.state.il.us/members/feigenholtzs/">Rep. Sara Feigenholtz</a> wielding the hammer on the same committee that heard Terri Bartlett’s testimony. The main sponsor of the bill prioritizing ADFs, Feigenholtz ranked second-highest among legislative recipients of money from Pfizer since the start of 2010, according to an analysis of data from the <a href="http://followthemoney.org/">National Institute on Money in State Politics</a>. The $6,200 she received during that period was more than she had received in the 14 previous years combined. Her bill passed the committee but later stalled in the Legislature and remains pending.</p>
<p>She did not return multiple requests for comment. Pfizer said its contributions to Feigenholtz go back 20 years and it would be “inaccurate and misleading” to suggest a tie to any one piece of legislation.</p>
<p>Bartlett said she doesn’t mind that Purdue was ultimately responsible for her invitation to testify, even though she didn’t know that at the time. She still supports the bill.</p>
<p>“I want to believe that in every pharmaceutical company there still remains some sort of humanity,” she said. “Saving life is expensive.”</p>
<p><strong>‘An addict can find a way’&nbsp;&nbsp;&nbsp;&nbsp;</strong></p>
<p>The FDA has walked a careful line on the new drugs, promoting them as a promising approach to discouraging abuse while acknowledging their real-world benefits remain largely theoretical.</p>
<p>Earlier this year, the agency highlighted the drugs in its “<a href="http://www.fda.gov/NewsEvents/Newsroom/FactSheets/ucm484714.htm">opioids action plan</a>,” issued after scathing criticism from some members of Congress that the FDA wasn’t doing enough to combat the epidemic.</p>
<p>Thus far, the agency has approved seven drugs with labeling suggesting they are “expected to” discourage abuse, based on studies conducted by pharmaceutical companies.</p>
<p>But the FDA has not yet concluded that any of the products have a “real-world impact” on measures like overdose or death, according to <a href="http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm374561.htm">Dr. Douglas Throckmorton</a>, an agency deputy director. He and other regulators predict, however, that the reformulations will eventually translate into public health results.</p>
<p>“We stand by those predictions,” Throckmorton said at a recent public meeting on the drugs. “We’re confident in the science, we’re confident in the assessments we conducted.”</p>
<p>Even some former FDA advisers who support expanded use of the drugs say they are only part of the solution. Dr. Lewis Nelson, who previously chaired an FDA panel on drug safety, notes that the drugs don’t deter the most common form of abuse: swallowing pills whole.</p>
<p>“Certainly, you might not eat one and get high,” he said. “You eat three and get high.”</p>
<p>At least one study found that while OxyContin’s reformulation coincided with many abusers switching to other drugs, other users still were able to defeat the pills’ technology and snort or inject the contents.</p>
<p>David Rook, a 40-year-old Henrico, Virginia, resident who now operates a recovery facility, was among them. Before entering treatment, he said, he would break down abuse-deterrent OxyContins and crush-resistant Opanas using water, lemon juice and a microwave.</p>
<p>“The truth is an addict can find a way to abuse a medication one way or the other,” he said.</p>
<p>A recent HIV outbreak in rural Indiana illustrates the sometimes unpredictable effect of ADFs on abusers’ behavior.</p>
<p>Approximately 210 people have tested positive for the virus in Scott County since 2014, a public health crisis linked to needle-sharing among abusers of Opana. <a href="http://www.endo.com/">Endo Pharmaceuticals</a> received approval for a reformulated version of the drug in 2011, making it harder to crush. As a result, many abusers switched from snorting the drug to injecting it with syringes, leading to the <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1515195">spread of the blood-borne HIV virus</a>, according to the state health commissioner and other officials. &nbsp;&nbsp;</p>
<p>Endo spokeswoman Heather Zoumas Lubeski declined to comment on the outbreak, but issued a statement saying, “Patient safety has always been a top priority for Endo and we are committed to providing patients with approved products that are safe and effective when used as prescribed.”</p>
<p>The FDA declined to approve labeling claims for Opana’s anti-abuse features, noting that the drug still can easily be cooked and injected.</p>
<p>Pfizer, Purdue, Endo and <a href="http://www.tevapharm.com/">Teva Pharmaceuticals Industries Ltd.</a> spent more than $20 million between 2012 and 2015 on federal lobbying efforts that included support of a bill that would require the FDA to gradually replace current opioids with harder-to-abuse versions that become available. Teva declined comment.</p>
<p><a href="https://keating.house.gov/">Rep. William Keating</a>, D-Mass., first introduced the bill in 2012 and tried again in 2013 and 2015. Like his colleagues at the state level, he employed the hammer-smashing routine to illustrate the medications’ crush-resistant properties.</p>
<p>Keating said the industry played no part in spurring the bill, even though the head of a nonprofit association funded by abuse-deterrent drugmakers spoke at the press conference introducing his legislation. He also received $2,500 in political contributions from makers of reformulated opioids in 2011 and 2012, a small fraction of his overall fundraising haul.</p>
<p>“My interest in this stems from when I was a district attorney and I got to see the lives that were lost,” Keating said in an interview.</p>
<p>While Keating’s bill has not received a vote in Congress, the FDA already has begun moving in the direction suggested by companies, mapping out a process for removing older opioids from the market when newer versions are shown to be more effective at thwarting abuse.</p>
<p>“You don’t have to pass a bill, necessarily, to change policy,” said Dan Cohen of the <a href="http://abusedeterrent.org/Default.aspx">Abuse Deterrent Coalition</a>, which represents smaller abuse-deterrent manufacturers.</p>
<p>The lack of real-world data on reformulated opioids is the main reason some federal officials haven’t embraced them.</p>
<p>The CDC did not recommend ADFs in its landmark opioid guidelines this year, the first-ever federal recommendations for doctors prescribing the drugs. Why? Frieden, the agency’s director, said his staff could not find any evidence showing the updated opioids actually reduce rates of addiction, overdoses or deaths.</p>
<p><em>Center for Public Integrity data reporter Ben Wieder contributed to this article.</em></p>
<p><strong><em>This story was co-published with&nbsp;</em></strong><em><a href="http://bigstory.ap.org/article/2179dcb0023847879d291804d7c9270b/drugmakers-push-profitable-unproven-opioid-solution">The Associated Press</a></em><strong><em>.</em></strong></p>
Terri Bartlett looks at a framed pictured of her deceased son Michael hanging on a wall of her McHenry, Ill., home. Two years after the overdose that killed her 21-year-old son,&nbsp;Bartlett traveled to Illinois’ state capital to champion an unlikely cause: revamped painkillers.&nbsp; In emotional testimony last year, she urged lawmakers to support a bill that would prioritize the new harder-to-crush pills, saying she believed her son would still be alive if abuse-deterrent formulations had been on the market then.
Matthew Perronehttps://www.publicintegrity.org/authors/matthew-perroneGeoff Mulvihillhttps://www.publicintegrity.org/authors/geoff-mulvihillLiz Essley Whytehttps://www.publicintegrity.org/authors/liz-essley-whyteDrugmakers set to gain as taxpayers foot new opioid costshttp://www.publicintegrity.org/node/20549Taxpayers could pay millions under new and proposed laws that favor higher-priced reformulated painkillers. Morphine;Opioid2016-12-15T10:56:39-05:002016-12-15T05:00:02-05:00<p>Critics say the answer pharmaceutical companies are pushing to address the ongoing opioid crisis <a href="http://www.publicintegrity.org/2016/12/15/20544/drugmakers-push-profitable-unproven-opioid-solution">boosts their profits</a> while forcing taxpayers to shoulder the costs.</p>
<p>Some drugmakers aim to replace ubiquitous painkillers such as Vicodin and Percocet with harder-to-abuse formulations that are patent-protected and command higher prices — a plan that could cost government-funded health programs <a href="http://bigstory.ap.org/article/cf44665291a349999bdb7931513c285f/drugmakers-set-gain-taxpayers-foot-new-opioid-costs">hundreds of millions of dollars</a> in higher medication expenses.</p>
<p>A pending measure in Illinois, for example, would cost taxpayers <a href="http://www.ilga.gov/legislation/billstatus.asp?DocNum=2743&amp;GAID=13&amp;GA=99&amp;DocTypeID=HB&amp;LegID=88589&amp;SessionID=88">$55 million</a> annually to cover the higher-priced drugs for state Medicaid recipients, according to an initial state analysis. A proposal in Ohio was estimated to bring <a href="https://www.legislature.ohio.gov/download?key=3527&amp;format=pdf">$167 million</a> in higher costs.</p>
<p>And on the federal level, an industry-backed provision benefiting reformulated opioids tucked into a law this summer will cost the federal government <a href="http://www.cbo.gov/sites/default/files/114th-congress-2015-2016/costestimate/hr4978.pdf">$75 million</a> in lost Medicaid payments over 10 years, according to an estimate by the Congressional Budget Office.</p>
<p><a href="https://www.publicintegrity.org/2016/09/18/20200/politics-pain-drugmakers-fought-state-opioid-limits-amid-crisis">Proponents of the drugs</a> say switching to the new formulations could save taxpayers money if addictions decline, though there is little evidence now that they reduce rates of either addiction or overdoses.</p>
<p>The prescription painkiller epidemic costs the U.S. economy <a href="http://journals.lww.com/lww-medicalcare/Fulltext/2016/10000/The_Economic_Burden_of_Prescription_Opioid.2.aspx">$78.5 billion</a> annually, according to a Centers for Disease Control and Prevention report this year.</p>
<p>“We have an enormous prescription-drug abuse problem in Illinois that’s costing a lot of money,” said Jonathan Pearl, chief of staff for Democratic Illinois <a href="http://www.housedem.state.il.us/members/cassidyk/">Rep. Kelly Cassidy</a>, who signed on to the industry-backed legislation requiring coverage of the new drugs. “This isn’t the only way to address it. It’s not a silver bullet, but it’s something.”</p>
<p>Still, industry critics worry that the focus on revamped painkillers is funnelling resources away from other measures needed to tame <a href="https://www.publicintegrity.org/2016/09/19/20201/pro-painkiller-echo-chamber-shaped-policy-amid-drug-epidemic">the nation’s drug epidemic</a>. The drugs typically make it harder for users to crush them to snort or inject, but still can be abused.</p>
<p>“I’m frustrated that people would be burning a lot of public energy and resources on issues that are not key to stopping the epidemic,” said <a href="http://deohs.washington.edu/faculty/franklin_gary">Dr. Gary Franklin</a>, a University of Washington research professor who also is a vice president with <a href="http://www.supportprop.org/">Physicians for Responsible Opioid Prescribing</a>, a group that advocates for reduced opioid prescribing.</p>
<p>Sweeping federal legislation passed this summer was designed to expand medication-based addiction treatment and overdose-reversal drugs through grants to state and local health providers. But lawmakers also included language long favored by drugmakers that exempts the companies from paying higher rebates worth $75 million over 10 years for reformulated opioids to Medicaid, the state-federal health plan for low-income Americans.</p>
<p>Industry advocates <a href="http://claad.org/wp-content/uploads/2016/03/Coalition-Comment-on-Line-Extension.pdf">argued for months</a> that reformulated opioids should not face the higher rebates, which they said discourage investment in abuse-deterrent technology — a stance the Obama administration eventually endorsed in its budget proposal.</p>
<p>Companies that make abuse-deterrent drugs, including <a href="http://www.purduepharma.com/">Purdue Pharma</a>, <a href="http://www.pfizer.com/">Pfizer</a> and <a href="http://www.endo.com/">Endo</a>, spent more than $1.7 million on lobbying efforts that included the opioid bill as it made its way through Congress.</p>
<p>Purdue spokesman Robert Josephson said his company supports <a href="https://www.publicintegrity.org/2016/09/18/20202/drugmakers-fought-domino-effect-washington-opioid-limits">public policies addressing the opioid epidemic</a>, “including through appropriate and affordable patient access to opioid pain medicines with abuse-deterrent properties.”</p>
<p>Pfizer spokeswoman Sharon Castillo gave similar reasons for her company’s support of the measure. An Endo spokeswoman declined to comment on the legislation.</p>
<p>The language sought by industry was <a href="http://docs.house.gov/meetings/IF/IF00/20160426/104878/BILLS-114-4978-U000031-Amdt-1.pdf">introduced</a> by retiring <a href="http://pitts.house.gov/">Rep. Joe Pitts</a>, R-Pa., who received more than $50,000 in political donations from makers of revamped opioids over the past decade.</p>
<p>Pitts did not grant repeated requests for an interview, but a spokeswoman offered a statement saying the amendment “would simply remove a penalty on manufacturers who do the right thing by creating an abuse-deterrent formulation.”</p>
<p><a href="https://www.wyden.senate.gov/">Sen. Ron Wyden</a>, D-Ore., made a last-ditch effort to kill the language in a House and Senate conference session.</p>
<p>A frequent critic of the pharmaceutical industry, despite receiving more than $40,000 from opioid drugmakers to his campaigns and his leadership PAC in the past decade, Wyden proposed eliminating the exemption and using the $75 million to fund addiction treatment for low-income pregnant women, who must forfeit their Medicaid prenatal coverage before seeking treatment.</p>
<p>“Colleagues, this is a pretty obvious choice,” Wyden said. “We’re either going to choose low-income, pregnant women — you do that by voting for my amendment — or you go with the companies who are getting a windfall here.”</p>
<p>His proposal was defeated. The law took effect in July.</p>
<p><em>Center for Public Integrity data reporter Ben Wieder and Associated Press reporter Geoff Mulvihill contributed to this article.</em></p>
<p><strong><em>This story was co-published with&nbsp;<a href="http://bigstory.ap.org/article/cf44665291a349999bdb7931513c285f/drugmakers-set-gain-taxpayers-foot-new-opioid-costs">The Associated Press</a>.</em></strong></p>
Taxpayers could pay millions under new and proposed laws that favor higher-priced reformulated painkillers. Pharmaceutical companies are backing efforts to require insurance coverage of tamper-resistant drugs, saying they’re important to dealing with an opioid abuse epidemic. But industry critics worry that the measures could funnel resources away from other needed measures.
Liz Essley Whytehttps://www.publicintegrity.org/authors/liz-essley-whyteMatthew Perronehttps://www.publicintegrity.org/authors/matthew-perronePro-painkiller echo chamber shaped policy amid drug epidemichttp://www.publicintegrity.org/node/20201Drugmakers and industry-backed nonprofits blanketed Washington with messages about the importance of painkillers amid opioid crisis.Pain;Medicine;Drug culture;Oxycodone;Morphinans;Opioids;Euphoriants;Nervous system;Clinical medicine;Pain management;Methadone;Analgesic2016-12-15T09:09:23-05:002016-09-19T00:01:00-04:00<p><strong><em>Editor's note:</em></strong><em>&nbsp;This is the second installment of an ongoing series. The first day covers&nbsp;the</em><em>&nbsp;</em><em><a href="https://www.publicintegrity.org/2016/09/18/20200/politics-pain-drugmakers-fought-state-opioid-limits-amid-crisis" target="_blank">state political efforts surrounding&nbsp;opioids</a>&nbsp;and a subsequent piece shows&nbsp;</em><em>how drugmakers are pushing a&nbsp;<a href="https://www.publicintegrity.org/2016/12/15/20544/drugmakers-push-profitable-unproven-opioid-solution" target="_blank">profitable, yet unproven, remedy</a>.</em></p>
<p>For more than a decade, members of a little-known group called the Pain Care Forum have blanketed Washington with messages touting prescription painkillers’ vital role in the lives of millions of Americans, creating an echo chamber that has quietly derailed efforts to curb U.S. consumption of the drugs, which accounts for two-thirds of the world’s usage.&nbsp;</p>
<p>In 2012, drugmakers and their affiliates in the forum sent a letter to U.S. senators promoting a hearing about an influential report on a “crisis of epidemic proportions”: pain in America. Few knew the report stemmed from legislation drafted and pushed by forum members and that their experts had helped author it. The report estimated more than 100 million Americans — roughly 40 percent of adults — suffered from chronic pain, an eye-popping statistic that some researchers call deeply problematic.</p>
<p>The letter made no reference to another health issue that had been declared an epidemic by federal authorities: drug overdoses tied to prescription painkillers. Deaths linked to addictive drugs like OxyContin, Vicodin and Percocet had increased more than fourfold since 1999, accounting for more fatal overdoses in 2012 than heroin and cocaine combined.</p>
<p>An investigation by the <a href="http://www.publicintegrity.org">Center for Public Integrity</a> and <a href="http://bigstory.ap.org/article/3d257452c24a410f98e8e5a4d9d448a7/pro-painkiller-echo-chamber-shaped-policy-amid-drug">The Associated Press</a> reveals that similar feedback loops of information and influence play out regularly in the nation’s capital, fueled by money and talking points from the Pain Care Forum, a loose coalition of drugmakers, trade groups and dozens of nonprofits supported by industry funding that has flown under the radar until now.</p>
<p>Hundreds of internal documents shed new light on how drugmakers and their allies shaped the national response to the ongoing wave of prescription opioid abuse, which has claimed the lives of roughly 165,000 Americans since 2000, according to federal estimates.</p>
<p>Painkillers are among the most widely prescribed medications in the U.S., but pharmaceutical companies and allied groups have a multitude of legislative interests beyond those drugs. From 2006 through 2015, participants in the Pain Care Forum <a href="https://www.publicintegrity.org/2016/09/18/20203/pharma-lobbying-held-deep-influence-over-opioids-policies">spent over $740 million lobbying</a> in the nation’s capital and in <a href="https://www.publicintegrity.org/2016/09/18/20200/politics-pain-drugmakers-fought-state-opioid-limits-amid-crisis">all 50 statehouses</a> on an array of issues, including opioid-related measures, according to an analysis of lobbying filings by the Center for Public Integrity and AP.</p>
<p>The same organizations reinforced their influence with more than $140 million doled out to political campaigns, including more than $75 million alone to federal candidates, political action committees and parties.</p>
<p>That combined spending on lobbying and campaigns amounts to more than 200 times the $4 million spent during the same period by the handful of groups that work for restrictions on painkillers. Meanwhile, opioid sales reached $9.6 billion last year, according to <a href="http://www.imshealth.com/">IMS Health</a>, a health information company.</p>
<p>“You can go a long, long way in getting what you want when you have a lot of money,” said Professor <a href="http://healthpolicy.fsi.stanford.edu/people/keith_humphreys">Keith Humphreys</a> of Stanford University, a former adviser on drug policy under President Barack Obama. “And it’s only when things get so disastrous that finally there’s enough popular will aroused to push back.”</p>
<p>Obama gave his first speech on the opioid epidemic last fall. In July, Congress passed its first legislation targeting the crisis, an election-year package intended to expand access to addiction treatment. But the law includes little new funding and no restrictions on painkillers, such as mandatory training for prescribers, a step favored by federal advisory panels.</p>
<p>Obama administration officials say they have tried to strike a balance between controlling the harms of opioids and keeping them available for patients.</p>
<p>“We did not want to deny people access to appropriate pain care,” said <a href="https://www.whitehouse.gov/ondcp/botticelli-bio">Michael Botticelli</a>, Obama’s drug czar. “We were all trying to figure out what the balance was, and that’s still the case going forward.”</p>
<p>Painkillers are modern versions of ancient medicines derived from the opium poppy, also the source of heroin. Prescription opioids were long reserved for the most severe forms of pain associated with surgery, injury or terminal diseases like cancer.</p>
<p>That changed in the 1990s with a surge in prescribing for more common ailments like back pain, arthritis and headaches. A combination of factors fueled the trend, including new medical guidelines, insurance policies and pharmaceutical marketing for long-acting drugs like OxyContin.</p>
<p>The drug’s manufacturer, <a href="http://www.purduepharma.com/">Purdue Pharma</a>, pleaded guilty and agreed to pay more than $600 million in fines in 2007 for misleading the public about the risks of OxyContin. But the drug continued to rack up blockbuster sales, generating more than $22 billion over the last decade.</p>
<p>Despite having no physical address or online presence, the Pain Care Forum hosts high-ranking officials from the White House, Food and Drug Administration and other agencies at its monthly gatherings.</p>
<p>Purdue’s Washington lobbyist, Burt Rosen, co-founded the forum more than a decade ago and coordinates the group’s meetings, which include dozens of lobbyists and executives.</p>
<p>Purdue declined to make Rosen available for interviews and did not answer specific questions about its lobbying activities or financial support for forum participants. Purdue said it supports a range of advocacy groups, including some with differing views on opioids.</p>
<p>“In practice and governance, the Pain Care Forum is like any of the hundreds of policy coalitions in Washington and throughout the nation,” the company said in a statement, adding: “Purdue complies with all applicable lobbying disclosure laws and requirements.”</p>
<p>While Purdue, <a href="http://www.endo.com/">Endo Pharmaceuticals</a> and other members have maintained the forum does not take policy positions, the AP and Center for Public Integrity's reporting shows the group’s participants have worked together to push and draft federal legislation, <a href="https://www.publicintegrity.org/2016/09/18/20202/drugmakers-fought-domino-effect-washington-opioid-limits">blunt regulations</a> and influence decisions around opioids.</p>
<p>Opioid drugmakers say they are striving to improve the safety of their products and how they are used. They point to new harder-to-crush pills and initiatives that, among other things, allow states to share databases designed to spot “doctor shopping” by patients.</p>
<p>Elsewhere, experts are reevaluating the effectiveness of opioids for most forms of chronic pain, noting little long-term research.</p>
<p>“The biggest myth out there is that there’s a conflict between reducing our dependence on opioids and improving care for patients in pain,” said Dr. <a href="http://www.jhsph.edu/faculty/directory/profile/2761/caleb-alexander">Caleb Alexander</a>, co-director of Johns Hopkins University’s Center for Drug Safety and Effectiveness. “It’s an artificial conflict, but there are lots of vested interests behind it.”</p>
<p><strong>‘The epidemic of pain’</strong></p>
<p>By spring 2014, the figure that 100 million Americans suffered from chronic pain was getting new attention: as a talking point for the nation’s top drug regulator.</p>
<p>The head of the FDA used the statistic to illustrate the importance of keeping painkillers accessible, despite the escalating toll of opioid addiction and abuse in American communities.</p>
<p>In an online essay, then-Commissioner Dr. Margaret Hamburg said reducing the toll was a “highest priority,” but that her agency had to “balance it with another major public health priority: managing the pain that affects an estimated 100 million Americans.”</p>
<p>That line populated her speeches and interviews for months.</p>
<p>But <a href="https://www.grouphealthresearch.org/our-research/our-scientists/vonkorff-michael-r/">Michael Von Korff</a> of the Group Health Research Institute, whose research contributed to the statistic, said the number has no connection to opioids. Instead, he said, it mostly represents “people with run-of-the-mill pain problems who are already managing them pretty well.”</p>
<p>Von Korff’s work is funded by federal, foundation and health insurance sources. He also is an officer with Physicians for Responsible Opioid Prescribing, a group pushing for restrictions on the drugs.</p>
<p>Pain Care Forum participants spent nearly $19 million on lobbying efforts that included the legislation requiring federal research on pain and the Institute of Medicine report that first highlighted the figure.</p>
<p>Concerns about the use of the statistic in connection with opioids and ties between some of the report authors and the pharmaceutical industry were covered by the <em><a href="http://archive.jsonline.com/watchdog/watchdogreports/chronic-pain-statistic-called-exaggerated-misleading-b99287713z1-264515601.html">Milwaukee Journal Sentinel</a> </em>in 2014.</p>
<p>Nearly half the experts assembled by the Institute of Medicine to write the 364-page report had served as leaders in Pain Care Forum-affiliated groups, such as the American Pain Foundation, the American Pain Society and the American Academy of Pain Medicine — all supported by industry funding.</p>
<p>Hamburg said in an email that the report was “another piece of scientific literature that helped inform the broader field,” which her agency had no role in producing.</p>
<p>The Pain Care Forum discussed the legislation that led to the report at its first meeting in February 2005, according to notes by one of the group’s principal members, The American Pain Foundation. Memos from the now-defunct foundation are among hundreds of documents obtained through public information requests by the AP and the Center for Public Integrity from the city of Chicago, which accused six drugmakers of misleading the public about opioid risks in an ongoing lawsuit.</p>
<p>In June 2006, the forum organized a Capitol Hill briefing headlined “The Epidemic of Pain in America.” Briefing materials included statements like: “Appropriate use of opioid medications like oxycodone is safe and effective and unlikely to cause addiction in people who are under the care of a doctor and who have no history of substance abuse.”</p>
<p>Attendees were asked to support a bill from then-Congressman Mike Rogers, which would later be rewritten by the forum and reintroduced in 2007 and 2009, according to the memos. It called for the Institute of Medicine — now a part of the National Academies of Sciences, Engineering and Medicine — to develop a comprehensive report on pain in America. Parts of the legislation eventually passed with Obama’s sweeping health care overhaul of 2010.</p>
<p>Rogers, a Republican from Michigan, received at least $310,000 in contributions from forum groups from 2006 to 2015, which went to his campaign and to a leadership account that he could use to donate to his peers.</p>
<p>Rogers, who left office last year, rejected the idea that he was influenced by the contributions, and said he began working on pain issues as a state senator after helping his brother through a series of back surgeries.</p>
<p>“I think they said, ‘This guy is a champion, he’s doing something we believe in and we want to support guys like that,’” he said.&nbsp;</p>
<p>Sen.&nbsp;<a href="http://www.hatch.senate.gov/public/index.cfm/biography">Orrin Hatch</a>, R-Utah, and former Sen. Chris Dodd, D-Conn., who together introduced the Senate version of the bill, received more than $360,000 and $190,000 respectively from forum participants.</p>
<p>Staffers for Hatch did not respond to repeated requests for comment. Dodd, who left office in 2011, said in a statement: “Sen. Hatch and I worked together to increase awareness and understanding of this serious medical condition in the hopes of providing relief to the millions of Americans who suffer from chronic pain.”</p>
<p>Phil Saigh, the executive director of the <a href="http://www.painmed.org/">American Academy of Pain Medicine</a>, said he informed the Pain Care Forum years ago that his group did not consider itself a member of the coalition. Yet the academy has continuously appeared in directories of forum participants since 2006, including as late as 2013, the most recent documents available.</p>
<p>The academy and the <a href="http://americanpainsociety.org/">American Pain Society</a> say some of the funding they receive from drugmakers is in the form of grants used for expenses tied to educational meetings and events. Both organizations also operate separate “corporate councils,” in which companies are granted meetings with physicians in exchange for annual payments up to the $20,000 range.</p>
<p>Jennifer Walsh, a spokeswoman for the <a href="http://www.nationalacademies.org/">National Academies of Sciences, Engineering and Medicine</a>, said, “We stand by our report, the committee, and the process that produced it.”</p>
<p>Experts who could personally profit from reports are prohibited from serving on its committees, she added. But the academies, which advise the federal government on scientific and medical topics, declined to release financial disclosure forms completed by panelists.</p>
<p>Those on opposite sides of the opioids debate agree that the report raised important points about pain treatment, including warnings about the addictiveness of painkillers.</p>
<p>After the report’s release in June 2011, the American Pain Foundation received $150,000 from Purdue to promote its findings through the Pain Care Forum. The foundation planned “congressional briefings and hearings” and “meetings with the leadership of various federal agencies,” according to a November 2011 letter.</p>
<p>The foundation closed the next year. Senate investigators had asked about the nonprofit receiving <a href="https://www.propublica.org/article/senate-panel-investigates-drug-company-ties-to-pain-groups">nearly 90 percent</a> of its funding from industry.</p>
<p>Meanwhile, a handful of lawmakers tried to draw attention to rising rates of painkiller abuse.</p>
<p>In 2010, then-Rep. Mary Bono, R-Calif., co-founded the Congressional Caucus on Prescription Drug Abuse, which focused on educating lawmakers about drug abuse. She clipped newspaper stories from her colleagues’ home states, but recalled, “They’d just say ‘Yeah, yeah, yeah,’ and move on to more pressing matters.”</p>
<p>Bono, whose family had dealt with opioid addiction, drafted legislation in 2010 designed to curb opioid prescribing by requiring the FDA to limit the labeling for OxyContin and related drugs to “severe pain.” OxyContin had long been marketed for a broader indication listed on the label as “moderate-to-severe pain.”</p>
<p>According to Bono, a Purdue lobbyist visited her and threatened to pull back on its state-level funding for drug abuse initiatives.</p>
<p>“They were just letting it be known that if I didn’t play nicer with them, they could cause some things to happen that I wouldn’t like,” she said.</p>
<p>Purdue said in a statement that it met with Bono to support “her efforts to stop prescription drug abuse.” The company says it does not oppose measures that “improve the way opioids are prescribed,” even when they could reduce sales. Former Rep. Bill Brewster, D-Oklahoma, a contract lobbyist for Purdue at the time, said in an email that he recalled the conversation as “cordial and constructive.”</p>
<p>Purdue spent nearly $800,000 on lobbying efforts that included Bono’s bill and subsequent versions of it. Pain Care Forum participants gave her campaigns more than $60,000 from 2006 through 2012.</p>
<p>Bono’s bill, the Stop Oxy Abuse Act, never received a congressional vote or hearing, even after Republicans regained control of the House in the November 2010 elections. She lost her congressional seat in 2012.</p>
<p><strong>‘What’s a regulator to do?’</strong></p>
<p>In June 2012, a senior FDA official gave a presentation to the Pain Care Forum titled: “FDA and Opioids: What’s a regulator to do?”</p>
<p>For several years, the FDA had been developing risk-management plans to reduce misuse of long-acting opioids like OxyContin. With oversight of drugmakers and their marketing efforts, the agency seemed perfectly positioned to tackle the problem.</p>
<p>But the plans that the FDA laid out lacked the major reforms suggested by the agency itself in 2009, when it announced the initiative. Instead of mandatory certification training for doctors and electronic registries to track opioid prescriptions to patients, the FDA official outlined much milder steps: Drugmakers would fund optional classes for prescribers and supply pharmacy brochures to patients about opioid risks.</p>
<p>Over several years, the FDA seemed to have backed away from any significant restrictions.</p>
<p>“It was my observation that the staff at FDA had really bought into the idea that pain was greatly undertreated in the United States,” said Dr. Elinore McCance-Katz, former chief medical officer with the <a href="http://www.samhsa.gov/">Substance Abuse and Mental Health Service Administration</a>, a federal health agency.</p>
<p>As early as December 2008, the Pain Care Forum was developing a strategy to “inform the process” at the FDA, according to meeting minutes from the American Pain Foundation.</p>
<p>When the FDA sought public comment on how to proceed, the forum helped generate more than 2,000 comments opposing new barriers to opioids, according to a 2010 foundation memo. Additionally, the forum produced a 4,000-signature petition opposing electronic registries for opioid prescriptions, which advocacy groups said would stigmatize patients.</p>
<p>Finally, in July 2010, the FDA assembled a panel of outside advisers — primarily physicians — to review its plans to manage opioid risks, including voluntary doctor training.</p>
<p>During a comment period, several members of the public warned it was a mistake. Dr. Nathaniel Katz, a former FDA adviser turned pharmaceutical consultant, traveled from Boston to implore the panel to support tougher requirements.</p>
<p>“The days of prescribers not being trained how to safely prescribe the number one medication in the United States have to be brought to an end by you today,” said Katz, who had previously chaired the FDA panel, according to a meeting transcript.</p>
<p>Ultimately, the panel voted 25-10 against the measures developed by the FDA, saying they would have little effect on opioid abuse. But the FDA put them in place anyway, one month after the agency briefed the Pain Care Forum on the plans. The FDA is not required to follow the recommendations of its advisory panels.</p>
<p>Agency officials said they decided that requiring certification for opioid prescribers would have been overly burdensome and disrupted care for patients.</p>
<p>“You can’t imagine the bitter screeds we hear from the prescribing community about the paperwork involved,” said Dr. <a href="http://www.fda.gov/AboutFDA/CentersOffices/ucm193984.htm">Janet Woodcock</a>, head of the FDA’s drug center. She added that the opioid crisis fundamentally stems from individual prescribing decisions, saying, “We don’t regulate medical practice.”</p>
<p>In the last two years, the FDA has placed several limitations on opioids, including adding new bolded warnings to immediate-release opioids such as Vicodin and Percocet. But prescriber training remains optional, even after a second FDA advisory panel again recommended the step earlier this year. Woodcock says the agency is still weighing that recommendation.</p>
<p>Currently, states such as Massachusetts are imposing their own physician-training requirements, a development that Katz attributes to a lack of federal action.</p>
<p>“The FDA failed to make a decision that could have averted many of the thousands of deaths we’re seeing per year,” Katz said. “So when people continue to die and communities continue to be devastated, then others will arise to do the policing.”</p>
<p><strong>Charting a ‘safer course’</strong></p>
<p>It was a federal agency hundreds of miles from Washington that finally sidestepped the influence of the pain care lobbyists.</p>
<p>The <a href="http://www.cdc.gov/">Centers for Disease Control and Prevention</a>, located in Atlanta, overcame threats of congressional investigation and legal action to publish the first federal guidelines intended to reduce opioid prescribing earlier this year.</p>
<p>Essentially, the agency said the risks of painkillers greatly outweigh the benefits for the vast majority of patients with routine chronic pain. Instead, the guidelines said, doctors should consider alternatives like non-opioid pain relievers and physical therapy.</p>
<p>For more than 15 years, CDC officials have tracked the precipitous rise in painkiller overdoses, which has been followed by a similar surge in heroin deaths. The CDC called the painkiller trend an epidemic in 2011, pushing Washington officials to do the same. The agency’s director, Dr. Tom Frieden, labeled opioids “dangerous medications” that “should be reserved for situations like severe cancer pain.”</p>
<p>When the CDC drafted its opioid guidelines, it moved quickly and quietly, initially giving outside groups just 48 hours to comment on draft guidelines distributed last September.</p>
<p>Opioid proponents said the guidelines were not based on solid evidence and criticized the CDC for not disclosing outside experts who had advised the effort, alleging that they included physicians who were biased against painkillers.</p>
<p>One pharma-aligned group, the <a href="http://www.wlf.org/">Washington Legal Foundation</a>, said the lack of disclosure constituted a “clear violation” of federal law. And a longtime Pain Care Forum participant — now known as the <a href="http://www.aapainmanage.org/">Academy of Integrative Pain Management</a> — asked congressional leaders to investigate how the CDC had developed the guidelines. A House committee asked the CDC to turn over documents about its advisers, but staffers said the probe did not uncover any violations.</p>
<p>Some of the most vigorous pushback came from Pain Care Forum affiliates embedded in the federal system. Under the 2010 pain legislation backed by the forum, the NIH had created a 19-member panel to coordinate pain research made up of federal officials, civilian physicians and pain advocates.</p>
<p>At the group’s December meeting, panelists with connections to the Pain Care Forum called the CDC’s approach “horrible” and “shocking.”</p>
<p>Dr. Richard Payne, a former board member of the American Pain Foundation, questioned whether the experts advising the CDC had “conflicts of interests in terms of biases, intellectual conflicts that needed to be disclosed.”</p>
<p>Payne himself had received more than $16,240 in speaking fees, meals, travel and other payments from drugmakers, including Purdue, between 2013 and 2015, according to federal records.</p>
<p>Myra Christopher, a long-time Pain Care Forum participant, said the panel should inform the CDC that it could not support the opioid guidelines and that their release should be delayed.</p>
<p>Christopher holds a chair at the nonprofit <a href="https://www.practicalbioethics.org/">Center for Practical Bioethics</a>, which receives funding from opioid drugmakers, and her position was established through a $1.5 million gift from Purdue. Both she and Payne also served on the Institute of Medicine panel on pain in America.</p>
<p>Christopher and Payne said they were thoroughly vetted before serving on the panel and disclosed their past work and activities. Federal officials who oversee the panel responded that all members met federal requirements to serve, including completing financial disclosure forms, though the NIH said those cannot be publicly released.</p>
<p>One week after the NIH panel’s critique, the CDC said it would delay finalizing its guidelines to allow more public comment and released a list of advisers. One of 17 “core experts” advising the agency reported serving as a paid consultant to <a href="http://www.cohenmilstein.com/">Cohen Milstein Sellers &amp; Toll</a>, the law firm suing multiple opioid drugmakers on behalf of the city of Chicago.</p>
<p>In March, the final guidelines appeared.</p>
<p>The first recommendation for U.S. doctors: “Opioids are not first-line therapy” for chronic pain. It was a statement considered common practice by many doctors as recently as the early-1990s, a decade before the Pain Care Forum formed in Washington.</p>
<p>"We're trying to chart a safer and more effective course for dealing with chronic pain," Frieden said. "We don’t expect any magic. We don’t expect things to be better in 15 months when it’s taken 15 years to get this much worse.”</p>
<p><em>Center for Public Integrity reporter Liz Essley Whyte and&nbsp;Associated Press&nbsp;reporter Geoff Mulvihill contributed to this article.</em></p>
<p><strong><em>This story was co-published with&nbsp;<a href="http://bigstory.ap.org/article/3d257452c24a410f98e8e5a4d9d448a7/pro-painkiller-echo-chamber-shaped-policy-amid-drug">The Associated Press</a>.</em></strong></p>
Demonstrators march along Main Street in Abingdon, Va., on July 20, 2007,&nbsp;to raise awareness about the abuse of OxyContin. Since 2000, prescription opioid abuse has claimed the lives of 165,000 Americans, according to federal estimates.
Matthew Perronehttps://www.publicintegrity.org/authors/matthew-perroneBen Wiederhttps://www.publicintegrity.org/authors/ben-wieder